Single Dose Intranasal Oxytocin and Cognitive Effects in Autism

Inclusion criteria

• Participants will be between 5 and 40 years of age.
• All subjects will have a diagnosis of autistic disorder or ASD that was confirmed by administration of the Autism Diagnostic Observation Schedule-WPS (ADOS-WPS) (30).
• Eligible participants must be able to perform the cognitive learning tasks.

Exclusion criteria

• Although we acknowledge that concomitant medications, or other types of intervention, may potentially bias study results, participants will be allowed to stay on concomitant medications and non-pharmacologic treatments, provided that no changes are made within 3 months prior to baseline and that no changes are made during the study.
• Individuals that are on antipsychotic drugs will be excluded from participation. All subjects must lack a significant medical history.
• Subjects with any condition, including alcohol and drug abuse, which might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being will be excluded.
• This includes, but is not limited to impairment of renal function, evidence or history of malignancy or any significant hematological, endocrine, respiratory, hepatic, cardiovascular or gastrointestinal disease.
• All female subjects of childbearing capacity will have a urine pregnancy test (a positive test will exclude the subject from participation).
• A pregnancy test will be conducted at both visits prior to drug administration. Uterine contractions may occur in women and are more likely to occur in pregnant women, especially towards the end of pregnancy.
• As a result, we exclude pregnant female patients, sexually active female patients on hormonal birth control and sexually active females who do not use two types of non-hormonal birth control.
• All interested potential subjects will be contacted via phone. If they meet eligibility criteria, two sessions that are approximately two weeks apart and approximately the same time of day will be scheduled. At their first visit, we will review the study and undergo informed consent procedures. Overall study procedures per visit are estimated to take approximately 2-3 hours per session, and are detailed in Table 2.